Heart FailureBIOWOMENNCT02344420
Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN
A study testing Echocardiography, Minnesota Living Heart Failure Questionnaire (MLHF) and Six minute walk test in people with Heart Failure, run by Biotronik SE & Co. KG at 1 site in Spain.
Trial summary
BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women. Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF etiology…) and compared in order to demonstrate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Echocardiography, Minnesota Living Heart Failure Questionnaire (MLHF) and Six minute walk test
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2015to 23 Dec 2021
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for a "De Novo" implantation of a CRT device according to ESC Guidelines
- Understand the nature of the procedure
- Give written informed consent
Who cannot join
- CRT Device replacements
- CRT upgrades
- Permanent / Persistent Atrial Fibrillation
- Age< 18 years
- Pregnant and breastfeeding women
- Subjects with irreversible brain damage from pre existing cerebral disease
Show all 11Show fewer
- Subjects with acutely de compensated heart failure
- NYHA Class IV Heart Failure
- Heart transplantation six months prior to the enrolment or expected within next 3 months.
- Cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
- Have a life expectancy of less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Compare the Cardiac Resynchronization Therapy (CRT) Response Rate in a Heart Failure (HF) Population With an Equal Distribution of Men and Women
BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women. Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF etiology…) and compared in order to demonstrate that women may respond even better than men.
Read the detailed description
Prospective, non-randomized, international, open, multicenter study. Patients that comply with the inclusion and exclusion criteria will be implanted with a BIOTRONIK CRT system.
The primary objective is to study the magnitude of CRT response measured as function of increase in Left Ventricular Ejection Fraction (LVEF) in order to demonstrate a superior CRT response in women.
The Secondary main objectives are:
- To study changes in major clinical variables during a 12M FU period in men and women
- To study how Left Ventricular End Diastolic Volume (LVEDV) and Left Ventricular End Systolic Volume (LVESV) change in men and women with CRT response
- To study CRT responders and value if there are significant gender differences at baseline with regards of presence of inter/intra ventricular dyssynchrony, HF etiology (ischemic versus non-ischemic cardiomyopathy), QRS morphology (LBBB vs. RBBB) and QRSd
- Observational assessment of how key baseline clinical variables are related to the patient's CRT response, to create a possible "gender specific" response model.
- Study the relationship between QRSd (amount of dyssynchrony) and CRT response in men and women
There are no study specific requirements for the implantation procedure of the CRT device; implantation will be performed according to the routine hospital's practice.
In order to obtain an equal distribution of males and females in the study population enrolled by the site, all the inclusions should be performed consecutively (based on the normal hospital flow of CRT candidates), but the difference in the enrolment rate by gender should not exceed > 2 by site at any time during the enrolment phase.
The study flowchart consists of a baseline assessment, implantation/pre-hospital discharge, 2 month Follow Up (FU), 6 month FU, 12 month FU, and final study.
Special assessments as echocardiography (echo), 6 minute walk test and Quality of Life test (QOL) will be performed at baseline, after 6 months and at one year follow-up.
12-lead electrocardiogram (ECG) will only be performed at baseline. Device testing, (Serious) Adverse (Device) Events ((S)A(D)E), and changes in medication will be collected during all planned study FUs throughout the duration of the study. A device interrogation outside the scheduled study FU window needs to be reported as unscheduled FU.
The timing for scheduled FUs is at 2 month, 6 month and 12 month after implantation (and pre-hospital discharge) with a time window of ± 1 month.
All the echo images and ECGs will be saved and sent to the respective Core Labs.
The estimated sample size is 494 patients: 247 men and 247 women.
- Conditions
- Heart Failure
- Being tested
- Echocardiography, Minnesota Living Heart Failure Questionnaire (MLHF), Six minute walk test, Self assessment score
- Keywords
- Heart Failure, CRT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
The devices used within the study are the legally marked CRT devices from BIOTRONIK. CRT-P and CRT-D. As this is a post market study, all devices have a CE label and are used within their intended use. There are no study specific limitations nor mandatory device settings for the study.
Subjects will undergo a standard echo assessment at baseline, 6 and 12 month follow up visit in order to assess the baseline characteristics and the changes as response to resynchronization.
Minnesota Living Heart Failure Questionnaire (MLHF)Behavioural
MLHF will be obtained at baseline, 6 and 12 month FU. The goal of this questionnaire is to measure the subjects perception of how their heart failure and treatment affect their life. Questions are focused on physical, socio-economic, and psychological impairments that persons with congestive heart failure frequently attribute to their condition.
Six minute walk testProcedure or surgery
The test will be performed at baseline, 6 and 12 month FU. The purpose of the test is to determine how far a patient can walk in six minute and relate it with the heart failure.
Self assessment scoreBehavioural
patient will complete a self assessment questionnaire at 2, 6 and 12 month FU for the calculation of the Packer Score at 12 month.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | As it is not a randomize trial there is only one study arm. Described interventions as echocariography, six minute walk test, Quality of Life test or self assessment score should be done in all patients. Receives: Procedure: Echocardiography; Behavioral: Minnesota Living Heart Failure Questionnaire (MLHF); Procedure: Six minute walk test; Behavioral: Self assessment score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU)
To study the magnitude of Cardiac Resynchronization Therapy (CRT) response in women measured as a function of improvement in LVEF at 12moth FU in order to demonstrate that CRT response in women is better than men.
Measured: Baseline, 6 and 12 month
Secondary outcomes (7)
Left Ventricular End Diastolic Volume (LVEDV)
Reverse left ventricular remodelling is a promising surrogate measure of outcome after CRT. Left ventricular diastolic volumes will be compared between men and women to see if there are differences.
Measured: Baseline, 6 and 12 month
Left Ventricular End Systolic Volume (LVESV)
Reverse left ventricular remodelling is a promising surrogate measure of outcome after CRT. Left ventricular systolic volumes will be compared between men and women to see if there are differences.
Measured: Baseline, 6 and 12 month
NYHA class
Clinical variable collect to evaluate patients heart failure
Measured: Baseline, 6 and 12 month Follow Up
Quality Of Life test (QOL score)
Test perform by the patient to measure the perception of how is the heart failure and it´s treatment affected in their daily routine.
Measured: Baseline, 6 and 12 month Follow Up
Patient's global self-assessment score
Questionnaire perform by the patient to evaluate how is the heart failure.
Measured: 2, 6 and 12 month Follow Up
6 minute walk test
Test perform by the patient to evaluate how is the heart failure.
Measured: Baseline, 6 and 12 month Follow Up
12 lead electrocardiogram (ECG)
A standard 12-lead ECG at 25 mm speed obtained. QRS with will be measured to relate with CRT response.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startAug 2015
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Jose MS Sancho-Tello, Physician, Principal investigator, Hospital Universitario La Fe de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344420
- Sponsor's protocol ID
- BIOTRONIK-CR017
- Acronym
- BIOWOMEN
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2014
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Cardiac Resynchronization Therapy (CRT) Response Rate in a Heart Failure (HF) Population With an Equal Distribution of Men and Women
- ClinicalTrials.gov ID
- NCT02344420
- Acronym / sponsor ID
- BIOWOMEN / BIOTRONIK-CR017
- Conditions
- Heart Failure
- Keywords
- Heart Failure, CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 26 Jan 2015 (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.
BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women. Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF etiology…) and compared in order to demonstrate that women may respond even better than men.
Detailed description
Prospective, non-randomized, international, open, multicenter study. Patients that comply with the inclusion and exclusion criteria will be implanted with a BIOTRONIK CRT system.
The primary objective is to study the magnitude of CRT response measured as function of increase in Left Ventricular Ejection Fraction (LVEF) in order to demonstrate a superior CRT response in women.
The Secondary main objectives are:
- To study changes in major clinical variables during a 12M FU period in men and women
- To study how Left Ventricular End Diastolic Volume (LVEDV) and Left Ventricular End Systolic Volume (LVESV) change in men and women with CRT response
- To study CRT responders and value if there are significant gender differences at baseline with regards of presence of inter/intra ventricular dyssynchrony, HF etiology (ischemic versus non-ischemic cardiomyopathy), QRS morphology (LBBB vs. RBBB) and QRSd
- Observational assessment of how key baseline clinical variables are related to the patient's CRT response, to create a possible "gender specific" response model.
- Study the relationship between QRSd (amount of dyssynchrony) and CRT response in men and women
There are no study specific requirements for the implantation procedure of the CRT device; implantation will be performed according to the routine hospital's practice.
In order to obtain an equal distribution of males and females in the study population enrolled by the site, all the inclusions should be performed consecutively (based on the normal hospital flow of CRT candidates), but the difference in the enrolment rate by gender should not exceed > 2 by site at any time during the enrolment phase.
The study flowchart consists of a baseline assessment, implantation/pre-hospital discharge, 2 month Follow Up (FU), 6 month FU, 12 month FU, and final study.
Special assessments as echocardiography (echo), 6 minute walk test and Quality of Life test (QOL) will be performed at baseline, after 6 months and at one year follow-up.
12-lead electrocardiogram (ECG) will only be performed at baseline. Device testing, (Serious) Adverse (Device) Events ((S)A(D)E), and changes in medication will be collected during all planned study FUs throughout the duration of the study. A device interrogation outside the scheduled study FU window needs to be reported as unscheduled FU.
The timing for scheduled FUs is at 2 month, 6 month and 12 month after implantation (and pre-hospital discharge) with a time window of ± 1 month.
All the echo images and ECGs will be saved and sent to the respective Core Labs.
The estimated sample size is 494 patients: 247 men and 247 women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Procedure: Echocardiography, Behavioral: Minnesota Living Heart Failure Questionnaire (MLHF), Procedure: Six minute walk test, Behavioral: Self assessment scoreAs it is not a randomize trial there is only one study arm. Described interventions as echocariography, six minute walk test, Quality of Life test or self assessment score should be done in all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for a "De Novo" implantation of a CRT device according to ESC Guidelines
- Understand the nature of the procedure
- Give written informed consent
Key exclusion criteria (11 listed)
- CRT Device replacements
- CRT upgrades
- Permanent / Persistent Atrial Fibrillation
- Age< 18 years
- Pregnant and breastfeeding women
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 |
|---|---|---|
| EchocardiographyThe devices used within the study are the legally marked CRT devices from BIOTRONIK. CRT-P and CRT-D. As this is a post market study, all devices have a CE label and are used within their intended use. There are no study specific limitations nor mandatory device settings for the study. Subjects will undergo a standard echo assessment at baseline, 6 and 12 month follow up visit in order to assess the baseline characteristics and the changes as response to resynchronization. | Procedure or surgery | Single Arm |
| Minnesota Living Heart Failure Questionnaire (MLHF)MLHF will be obtained at baseline, 6 and 12 month FU. The goal of this questionnaire is to measure the subjects perception of how their heart failure and treatment affect their life. Questions are focused on physical, socio-economic, and psychological impairments that persons with congestive heart failure frequently attribute to their condition. | Behavioural | Single Arm |
| Six minute walk testThe test will be performed at baseline, 6 and 12 month FU. The purpose of the test is to determine how far a patient can walk in six minute and relate it with the heart failure. | Procedure or surgery | Single Arm |
| Self assessment scorepatient will complete a self assessment questionnaire at 2, 6 and 12 month FU for the calculation of the Packer Score at 12 month. | Behavioural | Single Arm |
Primary outcome
Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU)
Time frame: Baseline, 6 and 12 month
To study the magnitude of Cardiac Resynchronization Therapy (CRT) response in women measured as a function of improvement in LVEF at 12moth FU in order to demonstrate that CRT response in women is better than men.
7 secondary outcomes
Left Ventricular End Diastolic Volume (LVEDV)
Time frame: Baseline, 6 and 12 month
Left Ventricular End Systolic Volume (LVESV)
Time frame: Baseline, 6 and 12 month
NYHA class
Time frame: Baseline, 6 and 12 month Follow Up
Quality Of Life test (QOL score)
Time frame: Baseline, 6 and 12 month Follow Up
Patient's global self-assessment score
Time frame: 2, 6 and 12 month Follow Up
6 minute walk test
Time frame: Baseline, 6 and 12 month Follow Up
12 lead electrocardiogram (ECG)
Time frame: Baseline
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 20 Jan 2022.
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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.
Maria Jose MS Sancho-Tello, Physician principal investigator
Hospital Universitario La Fe de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography, Minnesota Living Heart Failure Questionnaire (MLHF) and Six minute walk test in people with Heart Failure, run by Biotronik SE & Co. KG at 1 site in Spain.
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 3 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 20 Jan 2022. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU) (time frame: Baseline, 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.