Heart FailurePhase 4NCT00206232
Novel Treatment for Diastolic Heart Failure in Women
A Phase 4 study testing Spironolactone in people with Heart Failure, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are 18 years of age or older.
- Women with clinical heart failure for > 2 months.
- Women with left ventricular ejection fraction > 50% within 2 months of screening.
- Women with New York Heart Association class II or III heart failure symptoms.
- Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.
- Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
Show all 9Show fewer
- Blood Pressure no more than 150/95.
- Patient able to walk more than 50 meters at the time of enrollment.
- Signed informed consent.
Who cannot join
- Current treatment with spironolactone.
- Severe hepatic impairment.
- Creatinine > 2.5 mg/dl
- Potassium > 5.0 mEq/L
- Intolerance to spironolactone in the past.
- Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
Show all 11Show fewer
- Unstable angina or myocardial infarction within the past 4 weeks.
- Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
- Pregnant or lactating females.
- Participation in any other drug trial within 30 days prior to randomization.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine Heart Clinic
Houston, Texas, 77030
About this study
The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.
Read the detailed description
Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.
- Conditions
- Heart Failure
- Being tested
- Spironolactone
- Keywords
- Diastolic Heart Failure
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Aldactone
Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Active comparator | Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk distance
Measured: Baseline, then 3 and 6 months after randomization
Secondary outcomes (1)
Echocardiography parameters of diastolic function
Measured: Baseline, then 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Kurrelmeyer, Baylor College of Medicine
- Investigators
- Karla M Kurrelmeyer, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206232
- Sponsor's protocol ID
- H - 13988
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2005
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurrelmeyer KM, Ashton Y, Xu J, Nagueh SF, Torre-Amione G, Deswal A. Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. J Card Fail. 2014 Aug;20(8):560-8. doi: 10.1016/j.cardfail.2014.05.010. Epub 2014 Jun 4.
PubMed 24905296
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment for Diastolic Heart Failure in Women
- ClinicalTrials.gov ID
- NCT00206232
- Acronym / sponsor ID
- H - 13988
- Conditions
- Heart Failure
- Keywords
- Diastolic Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.
Detailed description
Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Active comparator | Drug: SpironolactoneRandomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. |
| Placebo | Placebo comparator | Drug: SpironolactoneRandomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women who are 18 years of age or older.
- Women with clinical heart failure for > 2 months.
- Women with left ventricular ejection fraction > 50% within 2 months of screening.
- Women with New York Heart Association class II or III heart failure symptoms.
- Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.
Key exclusion criteria (11 listed)
- Current treatment with spironolactone.
- Severe hepatic impairment.
- Creatinine > 2.5 mg/dl
- Potassium > 5.0 mEq/L
- Intolerance to spironolactone in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneAlso: AldactoneResearch subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months. | Drug | Placebo, Spironolactone |
Primary outcome
Six minute walk distance
Time frame: Baseline, then 3 and 6 months after randomization
1 secondary outcome
Echocardiography parameters of diastolic function
Time frame: Baseline, then 3 and 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Derived from this study: PubMed 24905296Kurrelmeyer KM, Ashton Y, Xu J, Nagueh SF, Torre-Amione G, Deswal A. Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. J Card Fail. 2014 Aug;20(8):560-8. doi: 10.1016/j.cardfail.2014.05.010. Epub 2014 Jun 4.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla M Kurrelmeyer, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Heart Failure, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk distance (time frame: Baseline, then 3 and 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.