EUCTR2006-002605-31-AT
Active, not recruiting
Not Applicable
ALDOSTERONE RECEPTOR BLOCKADE IN DIASTOLIC HEART FAILUREA double-blind, randomised, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failure - Aldo-DHF
ConditionsDiastolic Heart FailureMedDRA version: 8.1Level: LLTClassification code 10008908Term: Chronic heart failure
DrugsVerospiron T 25 mg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diastolic Heart Failure
- Sponsor
- Georg-August-Universität Göttingen
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Current heart failure symptoms consistent with NYHA II or beyond
- •· Left ventricular ejection fraction (LVEF) \= 50% at rest
- •· Sinus rhythm or atrial fibrillation
- •· if sinus rhythm Echocardiographic parameters of diastolic dysfunction (Grade \= I, see Appendix)
- •· Peak VO2 \= 25 ml/kg/min
- •· Males and females of age \= 50 years
- •· Written informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Patients will be excluded for ANY ONE of the following reasons:
- •· definite or probable pulmonary disease (VC\<80% or FEV1\<80% of reference values on spirometry)
- •· severe obesity (BMI \= 36 kg/m2\)
- •· psychological disorders with suspected interaction to study outcome
- •· Prior documented intolerance to an aldosterone receptor antagonist
- •· Prior documented systolic heart failure (LVEF \= 40%)
- •· Changes in concomitant medication within the last two weeks prior screening visit
- •· Significant coronary artery disease (current angina pectoris or ischemia on stress tests; untreated coronary stenosis \>50%; Myocardial infarction or CABAG within the last 3 months)
- •· Known contraindications for spironolactone
- •· Significant laboratory abnormalities (potassium \= 5\.1 mmol/L; hemoglobin \= 11g/dL, hematocrit \= 33%)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
ALDOSTERONE RECEPTOR BLOCKADE IN DIASTOLIC HEART FAILUREA double-blind, randomised, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failure - Aldo-DHFEUCTR2006-002605-31-DEGeorg-August-Universität Göttingen
Completed
Phase 2
Aldosterone receptor blockade in Diastolic Heart Failure: a double-blind, randomised, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failureDiastolic heart failureCirculatory SystemHeart failureISRCTN94726526Georg-August University of Göttingen (Georg-August-Universität Göttingen) (Germany)422
Active, not recruiting
Phase 1
ALdosterone antagonist Chronic HEModialysis Interventional Survival Trialend-stage renal failure (ESRF)cardiovascular complicationMedDRA version: 20.0Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10050441Term: Chronic renal insufficiencySystem Organ Class: 100000004857Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]EUCTR2012-002856-18-BECHRU de Brest825
Active, not recruiting
Not Applicable
ALdosterone antagonist Chronic HEModialysis Interventional Survival TrialEUCTR2012-002856-18-FRCHRU de Brest
Active, not recruiting
Phase 1
Effects of Spironolactone in Heart Failure with Preserved Ejection Fraction: Measured by CMR, Echo, Excercise Capacity and Quality of Life QuestionaireEUCTR2013-000867-10-GBniversity of Leeds51