Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01616381
Status:
UNKNOWN
Last Update Posted:
2018-05-07
First Post:
2012-06-01
Brief Title:
Sildenafil Versus Placebo in Chronic Heart Failure
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
Sildenafil in Heart Failure SilHF An Investigator Initiated Multinational Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SilHF
Brief Summary:
This protocol describes a 2-arm randomised controlled pilot study assessing the tolerance safety and efficacy of sildenafil compared to control The hypothesis is that sildenafil will be well tolerated and efficacious in patients with chronic heart failure NYHA class II and III with evidence of systolic dysfunction EF 40 and secondary pulmonary hypertension SPAP 40mmHg
Patients that satisfy the inclusion criteria will be randomized to sildenafil 40mg x 3 or placebo therapy for 6 months in a 21 blinded fashion The placebo group will be compared to the active therapy group and analysed for differences in the main study end-points Patient Global Assessment and 6-Minute Walk Test
The study will also assess safety tolerability symptoms and quality of life
Patients that satisfy the inclusion criteria will be randomized to sildenafil 40mg x 3 or placebo therapy for 6 months in a 21 blinded fashion The placebo group will be compared to the active therapy group and analysed for differences in the main study end-points Patient Global Assessment and 6-Minute Walk Test
The study will also assess safety tolerability symptoms and quality of life
Detailed Description:
It is estimated that 2-3 of the adult population suffers from heart failure HF and the prevalence is increasing The European Society of Cardiology ESC represents countries with a population 11 billion and it is estimated that approximately 30 million patients have HF in these 53 countries Heart failure is particularly prevalent in the elderly population and represents a major burden for both patients and the health services HF is present in over 10 of patients admitted to hospital and accounts for 2 of national health expenses Approximately 50 of these costs are related to hospitalisation
Despite optimal non-pharmacological pharmacological and device therapy the morbidity among HF patients is high with symptoms such as dyspnoea and fatigue that reduce quality of life Following diagnosis approximately 50 are dead after 4 years Forty percent of patients admitted to hospital with HF are either dead or rehospitalised within one year
During the last decade PDE5-inhibitors have been evaluated as a potential treatment for heart failure see scientific rationale and reference However these investigations have been small and there is still limited data Trials assessing the acute effects of PDE5-inhibition in patients with symptomatic HF due to systolic dysfunction have been performed primarily with sildenafil Due to the short half-life of sildenafil the drug is administered 3 times daily when studying its chronic effects
Previous studies have evaluated the 50 mg dose acutely and 50 mg 3 times daily during short-term chronic studies Importantly there is considerable off-label use of sildenafil in symptomatic heart failure patients in most European countries
Revatio is currently licenced for pulmonary hypertension group 1 The dosing scheme is 20mg x 3 However we suggest targeting a higher dose to achieve optimal clinical benefit in patients with heart failure and moderate congestion As mentioned above most of the clinical literature in patients with symptomatic heart failure has been done using the 50mg x 3 regimen However it is believed that in the proposed study using 40mg x 3 should be equally efficacious There is already considerable experience using this dosage scheme in heart failure patients locally
The hemodynamic profile of PDE-5 inhibitors is favourable with reduction in filling pressures both systemic and pulmonary vascular resistance accompanied by improvement in symptoms and submaximal and peak exercise performance This pilot study will evaluate the use of the PDE5-inhibitor sildenafil in patients with heart failure systolic dysfunction and documented secondary pulmonary hypertension
Despite optimal non-pharmacological pharmacological and device therapy the morbidity among HF patients is high with symptoms such as dyspnoea and fatigue that reduce quality of life Following diagnosis approximately 50 are dead after 4 years Forty percent of patients admitted to hospital with HF are either dead or rehospitalised within one year
During the last decade PDE5-inhibitors have been evaluated as a potential treatment for heart failure see scientific rationale and reference However these investigations have been small and there is still limited data Trials assessing the acute effects of PDE5-inhibition in patients with symptomatic HF due to systolic dysfunction have been performed primarily with sildenafil Due to the short half-life of sildenafil the drug is administered 3 times daily when studying its chronic effects
Previous studies have evaluated the 50 mg dose acutely and 50 mg 3 times daily during short-term chronic studies Importantly there is considerable off-label use of sildenafil in symptomatic heart failure patients in most European countries
Revatio is currently licenced for pulmonary hypertension group 1 The dosing scheme is 20mg x 3 However we suggest targeting a higher dose to achieve optimal clinical benefit in patients with heart failure and moderate congestion As mentioned above most of the clinical literature in patients with symptomatic heart failure has been done using the 50mg x 3 regimen However it is believed that in the proposed study using 40mg x 3 should be equally efficacious There is already considerable experience using this dosage scheme in heart failure patients locally
The hemodynamic profile of PDE-5 inhibitors is favourable with reduction in filling pressures both systemic and pulmonary vascular resistance accompanied by improvement in symptoms and submaximal and peak exercise performance This pilot study will evaluate the use of the PDE5-inhibitor sildenafil in patients with heart failure systolic dysfunction and documented secondary pulmonary hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-002829-21 | EUDRACT_NUMBER | None | None |