Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:32 AM
Study NCT ID:
NCT07431567
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Hypoxia on RIght VEntRicular Function in Healthy Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092779', 'term': 'RE1-silencing transcription factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single-center, double-blind, randomized controlled, cross-over study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right ventricular free wall strain', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'The primary endpoint is defined as the right ventricular free wall strain (RVFWS) from condition normobaric normoxia to condition 4000m for group 1 and from normobaric normoxia to condition 2500m for group 2 at rest. RVFWS will be measured by speckle tracking strain analysis according to the guidelines of the European Association of Cardiology. Speckle tracking echocardiography allows to assess the right ventricular volume and true global RV function without relying on geometric assumption and is a valuable clinical bedside tool for assessing myocardial strain. Tomtec software (Philipps) will be used.'}], 'secondaryOutcomes': [{'measure': 'Tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in tricuspid annular plane systolic excursion (TAPSE) \\[cm\\] between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'Right ventricular-arterial coupling', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in TAPSE/sPAP and RVFWS/sPAP between the conditions at rest and during exercise, measured by echocardiography, as a validated, noninvasive measure of right ventricular-arterial coupling.'}, {'measure': 'RV/PA', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in RV/PA ratio between the conditions at rest and during exercise, measured by echocardiography according to the guidelines of the European Association of cardiology.'}, {'measure': 'Stroke volume', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in stroke volume based on the left ventricular outflow tract diameter and the velocity time integral over the aortic valve in the apical 5-chamber view or the apical long axis view \\[ml\\] between the conditions at rest and during exercise, measured by speckle tracking strain analysis according to the guidelines of the European Association of Cardiology.'}, {'measure': 'Heart rate', 'timeFrame': 'It will be assessed at baseline and continuously measured during each condition (1 hour resting period and during the 10 minutes cycling).', 'description': 'Differences in heart rate \\[bpm\\] and HRV between the conditions at rest and during exercise, continuously measured throughout the intervention by electrocardiogram connected to an Alice pdx.'}, {'measure': 'Blood pressure', 'timeFrame': 'It will be measured at baseline once and during each condition six times: Four times during the resting period (every 15 min) and two times during low load cycling.', 'description': 'Differences in blood pressure between the conditions at rest and during exercise, measured by a digital sphygmomanometer four times at rest and four times during low load cycling \\[mmHg\\] and continuously measured by a PPG-based Wrist-monitor (biobeat).'}, {'measure': 'Borg Rating of Perceived Exertion Scale (CR10)', 'timeFrame': 'Measured at baseline and in each condition twice: Once at the end of the resting condition and again at the end of the cycling exercise.', 'description': 'Differences in Borg Rating of Perceived Exertion Scale (CR10) between the conditions at rest and during exercise. Measured through showing a paper with the 10 categories and the participant points to the according category which describes the current breathing difficulty.'}, {'measure': 'Oxygen saturation', 'timeFrame': 'It will be assessed at baseline and continuously measured during each condition (1 hour resting period and during the 10 minutes cycling).', 'description': 'Differences in oxygen saturation \\[%\\] between the conditions at rest and during exercise, continuously measured throughout the intervention by an oximeter connected to an Alice pdx.'}, {'measure': 'Lung tissue oxygenation', 'timeFrame': 'It will be assessed at baseline and continuously measured during each condition (1 hour resting period and during the 10 minutes cycling).', 'description': 'Differences in lung tissue oxygenation between the conditions at rest and during exercise, assessed using near infrared spectroscopy (NIRS) continuously measured throughout the intervention according to our SOP.'}, {'measure': 'Brain oxygenation', 'timeFrame': 'It will be assessed at baseline and continuously measured during the 1 hour resting period during each condition, and during the 10 minutes cycling.', 'description': 'Differences in brain oxygenation between the conditions at rest and during exercise, assessed using near infrared spectroscopy (NIRS) continuously measured throughout the intervention according to our SOP.'}, {'measure': 'Respiratory effort', 'timeFrame': 'It will be assessed at baseline and continuously measured during each condition (1 hour resting period and during the 10 minutes cycling).', 'description': 'Differences in respiratory effort abdominal and chest using zRIP belts between the conditions at rest and during exercise connected to an Alice pdx.'}, {'measure': 'Multiomics profiles', 'timeFrame': 'A blood sample will be collected during each condition after 1 hour of rest.', 'description': 'Differences in multiomics profiles between the conditions at rest, assessed using mass spectrometry analysis of blood serum collected from venous blood from the V. antecubita, will be evaluated to determine the effects of acute hypoxia and group-specific responses.'}, {'measure': 'Arterial blood gas analysis', 'timeFrame': 'A blood sample will be collected during each condition after 1 hour of rest.', 'description': 'Differences in arterial blood gas analysis (ABGA) between the conditions at rest, collected through puncture of the A. radialis by a trained physician.'}, {'measure': 'Right ventricular size', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in right ventricular size between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'End-diastolic diameter', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition once at rest.', 'description': 'Differences in end-diastolic diameter between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'Fractional area change', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in fractional area change between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'Maximal tricuspid regurgitation velocity', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition three times: Once after 1 hour in the specific condition at rest, then during the 5 min of 30 Watt cycling and during the 5 min of 60 Watt cycling.', 'description': 'Differences in maximal tricuspid regurgitation velocity between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'Pulmonary acceleration time', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition once at rest.', 'description': 'Differences in pulmonary acceleration time between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}, {'measure': 'Diastolic dysfunction grade', 'timeFrame': 'It will be assessed once at baseline in rest and during each condition once at rest.', 'description': 'Differences in diastolic dysfunction grade between the conditions at rest and during exercise, measured according to the guidelines of the European Association of cardiology.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['right ventricular free wall strain', 'RVFWS', 'right ventricular function', 'tissue oxygenation', 'breathing difficulty', 'blood gas', 'heart rate'], 'conditions': ['Hypoxia', 'Normobaric Hypoxia', 'Altitude Hypoxia', 'Right Heart Function']}, 'descriptionModule': {'briefSummary': 'More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland. At high altitude, less oxygen is available, which places stress on the body-particularly on the heart, which has to pump blood through the lungs. How the healthy heart, especially the right ventricle, responds to this stress is still not well understood. Therefore, this study investigates how the heart responds to simulated altitudes of 2,500 m and 4,000 m, both at rest and during light physical activity. The present investigation focuses on healthy individuals in order to establish a reference for future comparisons with patients suffering from cardiopulmonary diseases. The primary objective is to assess how right ventricular function changes under conditions of reduced oxygen availability. In addition, vital signs, changes in blood gases, oxygen levels in blood and tissue and shortness of breath are assessed. The "altitude" is simulated using a special gas mixture that participants inhale. Healthy participants undergo three altitude conditions (490, 2,500, and 4,000 m above sea level). The order of the altitude conditions is assigned at random. The aim is to better understand how the right ventricle and other parameters respond to low-oxygen conditions and how affected patients can be better supported in the future.', 'detailedDescription': "Outdoor activities in the mountains are becoming increasingly popular. At higher altitudes, the air contains less oxygen, which puts extra strain on the body-especially on the heart. The right side of the heart plays a key role in pumping blood through the lungs and may need to work harder when oxygen levels are low. While the heart's response to long-term altitude exposure is relatively well known, much less is understood about how the healthy heart reacts to short-term (acute) exposure to low oxygen, particularly during light physical activity. This study aims to better understand how the healthy right ventricle responds to short-term simulated altitude exposure. Healthy participants will be exposed to different oxygen levels that correspond to altitudes of 490 m (near sea level), 2,500 m, and 4,000 m, both at rest and during light cycling exercise. By studying healthy individuals first, the results will provide an important reference for future studies in patients with heart or lung disease.\n\nThe main focus of the study is to measure changes in right ventricular function, assessed using a non-invasive heart ultrasound technique called speckle-tracking echocardiography. In addition, heart rate, blood pressure, oxygen saturation, and symptoms such as shortness of breath and leg fatigue will be recorded.\n\nThe study is conducted at a single center and uses a randomized, double-blind, cross-over design, meaning that each participant undergoes all altitude conditions in a random order, and neither the participants nor the investigators know which altitude is being simulated at a given time.\n\nParticipants Only healthy adults aged 18-80 years will be included. Participants must live below 800 m above sea level and must not have been exposed to higher altitudes for more than 24 hours in the three weeks before participation. Individuals with significant medical conditions, pregnancy, need for long-term oxygen therapy, or inability to follow the study procedures will be excluded.\n\nStudy procedures\n\nEach study visit includes:\n\n* A short resting period\n* Measurement of vital signs (heart rate, blood pressure, oxygen saturation)\n* Heart ultrasound at rest\n* A 10-minute low-intensity cycling exercise\n* Repeated heart ultrasound and symptom assessment during exercise\n* Low-oxygen conditions are created using a special gas mixture that participants breathe through a mask. Each condition is separated by a sufficient wash-out period to ensure recovery.\n\nStudy size and duration Based on statistical calculations, 18 participants will be recruited to allow balanced allocation across all study conditions and to account for potential dropouts. Participation may take place over two to three days, depending on the preferred schedule of the participant. The days can be spread or be spread over several weeks, depending on individual availability.\n\nAim of the study The goal of this study is to improve understanding of how the healthy right side of the heart responds to short-term low-oxygen exposure at rest and during light exercise. This knowledge will help interpret future findings in patients with heart or lung disease and may contribute to safer recommendations for physical activity at altitude."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* 18-80 years (age group young: 18-39.99 years / age group older: 40-80 years)\n* All sex and genders -Living \\<800m and without altitude exposure \\> 2500 m and \\> 24h within the last three weeks\n\nExclusion Criteria:\n\n* \\<18, \\>80 years old -Any diagnosed cardiopulmonary condition including past HAPE\n* Other clinically significant severe concomitant disease states (e.g. renal, hepatic dysfunction, etc.)\n* Inability to follow the procedures of the study due to language problems, psychological neurological disorders or orthopaedic disorders\n* Participants permanently living \\>800m and altitude exposure \\> 2500 m and \\>24h within the last three weeks\n* Pregnancy: Participants will be asked if pregnant or not, no screening for undetected pregnancy\n* Lactating women -Participation in other study with active treatment'}, 'identificationModule': {'nctId': 'NCT07431567', 'acronym': 'RIVER-H', 'briefTitle': 'Effect of Acute Hypoxia on RIght VEntRicular Function in Healthy Adults.', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Acute Hypoxia on RIght VEntRicular Function. A Single-Center, Double-Blind, Randomized Controlled Cross-Over Trial.', 'orgStudyIdInfo': {'id': 'RIVER-H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm ABC', 'description': 'The participant receives first normobaric normoxia (A), then normobaric hypoxia equal to 2500 m.a.s.l. (B) then normobaric hypoxia representing 4000 m.a.s.l. (C). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}, {'type': 'OTHER', 'label': 'Arm ACB', 'description': 'The participant receives first normobaric normoxia (A), then normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric hypoxia equal to 2500 m.a.s.l. (B). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}, {'type': 'OTHER', 'label': 'Arm BAC', 'description': 'The participant receives first normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric normoxia (A), then normobaric hypoxia representing 4000 m.a.s.l. (C). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}, {'type': 'OTHER', 'label': 'Arm BCA', 'description': 'The participant receives first normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric normoxia (A). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}, {'type': 'OTHER', 'label': 'Arm CAB', 'description': 'The participant receives first normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric normoxia (A), then normobaric hypoxia equal to 2500 m.a.s.l. (B). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}, {'type': 'OTHER', 'label': 'Arm CBA', 'description': 'The participant receives first normobaric hypoxia representing 4000 m.a.s.l. (C), then normobaric hypoxia equal to 2500 m.a.s.l. (B), then normobaric normoxia (A). Condition A represents the control.', 'interventionNames': ['Other: Normobaric Hypoxia']}], 'interventions': [{'name': 'Normobaric Hypoxia', 'type': 'OTHER', 'otherNames': ['rest', 'low intensity cycling', 'normobaric normoxia'], 'description': 'Normobaric hypoxia according to 408m (control/normobaric normoxia), 2500 m and 4000 m above sea-level at rest for 1 hour and at low intensity cycling for 10 minutes (5 min 30 W, 5 min 60 W).', 'armGroupLabels': ['Arm ABC', 'Arm ACB', 'Arm BAC', 'Arm BCA', 'Arm CAB', 'Arm CBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Mona Lichtblau, PD Dr. med.', 'role': 'CONTACT', 'email': 'mona.lichtblau@usz.ch', 'phone': '0432538176'}, {'name': 'Carmen Wick, Cand. PhD', 'role': 'CONTACT', 'email': 'carmen.wick@usz.ch', 'phone': '+41 43 253 44 05'}], 'facility': 'Consultant Clinic of Pulmonology, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Mona Lichtblau, PD Dr. med.', 'role': 'CONTACT', 'email': 'mona.lichtblau@usz.ch', 'phone': '+41 44 255 22 20'}, {'name': 'Carmen Wick, Cand. PhD', 'role': 'CONTACT', 'email': 'carmen.wick@usz.ch', 'phone': '+41 43 253 44 05'}, {'name': 'Mona Lichtblau, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carmen Wick, Cand. PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alessandro Vella, Cand. PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Consultant Clinic of Pulmonology, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Mona Lichtblau, PD Dr. med.', 'role': 'CONTACT', 'email': 'mona.lichtblau@usz.ch', 'phone': '+41 442552220'}, {'name': 'Carmen Wick, Cand. PhD', 'role': 'CONTACT', 'email': 'carmen.wick@usz.ch', 'phone': '+41 43 253 44 05'}], 'overallOfficials': [{'name': 'Mona Lichtblau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized individual participant data (IPD) are planned to be shared via an appropriate data repository, such as Zenodo. Corresponding standard operating procedures (SOPs) for our department are currently under development.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mona Lichtblau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Mona Lichtblau', 'investigatorAffiliation': 'University of Zurich'}}}}