Diastolic Heart Failure
Conditions
Interventions
HFpEF patients will be recruited from out-patient clinics. The diagnosis of
HFpEF will be established in accordance to the recommendations of the European
Society of Cardiology. Patients have to be
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: HFpEF patients over 18 years old and concomitant arterial hypertension, overweight or obesity and pulmonary hypertension will be recruited from the outpatient clinic.
Exclusion criteria
Exclusion criteria: * A history of acute coronary syndrome, coronary revascularization, evidence of reversible ischaemia or stroke within the previous 6 months.;* Valvular disease (more than moderate mitral or aortic regurgitation or greater than mild aortic or mitral stenosis).;* Hypertrophic, or infiltrative or inflammatory myocardial disease (e.g., amyloid, sarcoid).;* Pericardial disease, cor pulmonale or primary pulmonary arteriopathy.;* Use of nitrates or anticipated future need for nitrate therapy.;* Previous statin-induced myopathy or hypersensitivity reaction to statins or PDE5 inhibitors.;* Neuromuscular, orthopedic, or other non-cardiac condition that prevents the individual from exercise testing on a bicycle ergometer or from walking in a hallway.;* Non-cardiac condition that limits life expectancy to less than 1 year at the time of study entry, based on the judgment of the physician.;* History of reduced ejection fraction (less than 50%).;* Implanted metallic device that will interfere with MRI examination (in people without atrial fibrillation).;* Severe kidney dysfunction (estimated glomerular filtration rate [GFR] less than 20 ml/min/1.73m2 by modified modification of diet in renal disease [MDRD] equation).;* Pregnant or not using an effective form of contraception.;* Hemoglobin level of less than 10 g/dL (=6.2 mmol/l).;* Taking alpha antagonists or cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine, or serum protease inhibitors for HIV).;* Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance.;* Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease).;* Severe liver disease (aspartate aminotransferase [AST] level greater than three times the normal limit, alkaline phosphatase or bilirubin greater than two times the normal limit).;* In being consistent with American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, people with dyspnea and risk factors for coronary artery disease should have had a stress test and those people with a clinically indicated stress test demonstrating significant ischemia in the 1 year before study entry will be excluded.;* Previous or planned heart transplantation.;* Chronic muscle disease or an unexplained creatine kinase level of more than 2.5 times of the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Hemodynamics during low dose dobutamine stress testing 2) Extent of diastolic dysfunction determined by echocardiography 3) Magitude of LV hypertrophy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Plasma levels of cGMP | — |
Countries
Netherlands
Outcome results
None listed