- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475042
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction (STADIA-HFpEF)
September 18, 2020 updated by: Mariëlle Scheffer
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. A 35-week, Single-center, Prospective, Double-blind, Controlled, Randomized, 2x2 Crossover, Interventional Phase II Study, Investigating the Effect of Treatment With Dapagliflozin 10mg od on Left Ventricular Distensibility in Patients With Early HFpEF.
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marielle Scheffer, MD
- Phone Number: 0031205994889
- Email: mailcardio.research@olvg.nl
Study Locations
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1091
- Recruiting
- OLVG
-
Contact:
- Marielle Scheffer
- Phone Number: 0031205994889
- Email: mailcardio.research@olvg.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years at time of screening
Symptomatic chronic heart failure patients with diagnosis of heart failure and:
- NYHA class II-IV
- Preserved systolic Left Ventricular (LV) function, defined by: LV Ejection Fraction (LVEF) ≥ 50% and LV end-diastolic volume index <97 ml/m2
Evidence of diastolic LV dysfunction and at least 1 out of the 5 following additional criteria:
- H2FPEF score ≥ 6;
- HFA-PEFF score ≥ 5;
- Pulmonary capillary wedge pressure > 15 mmHg at rest or > 25 mmHg with exercise assessed with right heart catheterization;
- Cardiac MRI T1 derived extracellular volume <29% at screening
- Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit
- Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial
Exclusion Criteria:
- Reduced systolic LV function (LVEF < 50%), measured at any time point in the history of the patient
- Obstructive coronary artery disease with evidence of ischemia
- Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
- More than mild valve stenosis
- More than moderate aortic and/or mitral valve regurgitation
- Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. hemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (stress cardiomyopathy), hypertrophic (obstructive) cardiomyopathy or known pericardial constriction
- History of mitral valve repair or replacement
- Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm at screening
- Acute decompensation that requires intravenous loop diuretics
- Systolic blood pressure ≥ 180 mmHg. If SBP > 150 mmHg and < 180 mmHg, the patient should be receiving at least 3 antihypertensive drugs at screening or baseline visit
- Symptomatic hypotension and/or a SBP < 100 mmHg at screening or baseline visit
- Impaired renal function, defined as eGFR < 30 ml/min/1.73 m2
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal or history of cirrhosis with evidence of portal hypertension
- Hemoglobin < 9 g/dl at screening
- Chronic obstructive pulmonary disease, more than GOLD class 2
- Pulmonary function test with FEV1/FVC < 80%
- Primary pulmonary arterial hypertension
- Type 1 Diabetes Mellitus
- History of ketoacidosis
- Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix or low risk prostate cancer (biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a)
- Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 3 months prior to screening visit. Discontinuation of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor for the purposes of study enrolment is not permitted
- Pregnancy or lactation
- Any (clinical) condition that, in the investigator's opinion, would jeopardize patients safety while participating in this trial, or may prevent the patient from adhering to the trial protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A
Dapagliflozin - washout period - placebo
|
Placebo
10mg od
|
ACTIVE_COMPARATOR: Group B
Placebo - washout period - Dapagliflozin
|
Placebo
10mg od
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left Ventricular (LV) e'
Time Frame: 13 weeks
|
echocardiographically measured
|
13 weeks
|
E/e'/LV end-diastolic volume index
Time Frame: 13 weeks
|
echocardiographically measured
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kansas City Cardiomyopathy Questionnaire
Time Frame: 13 weeks
|
13 weeks
|
|
6-minute walk test
Time Frame: 13 weeks
|
13 weeks
|
|
Left atrial volume
Time Frame: 13 weeks
|
Echocardiographically derived volume
|
13 weeks
|
Diastolic parameters
Time Frame: 13 weeks
|
Echocardiographically derived function, filling and compliance of Left Ventricular
|
13 weeks
|
Left atrial function
Time Frame: 13 weeks
|
Echocardiographically derived strain analysis, resevoir, conduit and booster pump function
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ANTICIPATED)
November 1, 2021
Study Completion (ANTICIPATED)
May 1, 2022
Study Registration Dates
First Submitted
July 8, 2020
First Submitted That Met QC Criteria
July 16, 2020
First Posted (ACTUAL)
July 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.185
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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