Diastolic heart failure and diabetes mellitus type II
Conditions
Interventions
Trade Name: Torasemid
Product Name: Torasemid
Product Code: Torasemid
Pharmaceutical Form: Tablet
INN or Proposed INN: TORASEMIDE
CAS Number: 56211-40-6
Current Sponsor code: Torasemide
Other descript
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed, written informed consent • Males or females • Age = 18 years • Diagnosed Diastolic Heart Failure according to the ESC guidelines (1)Signs or symptoms of heart failure, 2)Normal or mildly abnormal left ventricular ejection fraction (LVEF), 3)Evidence of diastolic left ventricular (LV) dysfunction) • PIP = 110 ng/ml or PIP = 70 ng/ml if left atrial volume (LAV) > 29 ml/m² • Diabetes type II • Women of childbearing potential must test negative for pregnancy and must agree to use a highly effective contraceptive method (defined as pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: • Women during the lactation period, pregnant or of childbearing potential not using an effective contraceptive method • Cardiac valve disease defined as regurgitation =grade 2 • Chronic dialysis • Significant liver disease • Malignant tumor • Metabolic bone disease, autoimmune diseases or hyperthyroidism • Prior documented intolerance to torasemide, furosemide, or sulfonylureas • Known contraindications for torasemide or furosemide, especially hypovolemia, hypokalemia (<3,6 mmol/l), hyponatremia (< 135 mmol/l) • Significant disorder of micturition • Treatment with loop diuretics (e.g. torasemide, furosemide) at the time of baseline visit and throughout entire course of the trial. Patients with loop diuretics will undergo a washout of at least 5 (±2) days weeks after inclusion contact • Treatment with mineralocorticoid receptor antagonists • Changes in concomitant medication within the washout period • Any patient characteristic that may interfere with compliance with the trial protocol, such as dementia, substance abuse, history of non-compliance with prescribed medications or medical appointments • Concomitant participation in other clinical trials (Participation in another clinical trial within the last 30 days before enrollment) • Missing willingness of the patient regarding storage and transfer of pseudonymized health data • Patient is institutionalized because of legal or regulatory order (according to AMG § 40(1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to determine whether torasemide is superior to furosemide in reducing one marker (PIP) of cardiac fibrosis in subjects with diastolic heart failure and diabetes type II.;Secondary Objective: Secondary objectives of this trial are to determine whether torasemide is superior to furosemide in improving exercise capacity and diastolic function, as well as quality of life, neuroendocrine activation in subjects with diastolic heart failure and diabetes type II. The trial also investigates clinical safety aspects. ;Primary end point(s): Change in serum concentration of serum carboxy-terminal peptide of procollagen type I (PIP) at 9 months compared to baseline;Timepoint(s) of evaluation of this end point: at 9 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in exercise capacity (peak VO2 on spiroergometry, 6-minutes walking distance) at 9 months • Change in echocardiographic parameters of diastolic function • (E/A, E/E´, EDT, IVRT, S/D, AR, Vp, PVARdur, Adur, Tei-Index, LV mass, LA-area) at 9 months • Change in heart failure status (NYHA, signs and symptoms) at 9 months • Change in neuroendocrine activation (natriuretic peptides) at 9 months • Change in quality of life at 9 months • Clinical tolerability of trial medication will be assesses at all visits. • Change in laboratory parameter (CRP) at 9 months ;Timepoint(s) of evaluation of this end point: at 9 months compared to baseline tolerability: at all visits | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Carsten Tschöpe
Charité Universitätsmedizin Berlin
Outcome results
None listed