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HypertensionRETREAT-FRAILNCT03453268

Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP).

A study testing STEP DOWN strategy in people with Hypertension, run by Assistance Publique - Hôpitaux de Paris at 124 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Hypertension
What is being tested?
STEP DOWN strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,048 participants
Where
124 sitesFrance
Study dates
2 Oct 2018to 15 Aug 2024
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 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Male and female patients aged 80 and over
  • Patients living in nursing homes
  • Patients with a SBP < 130 mmHg measured in Medical-Social Institutions using the connected blood pressure monitor supplied for the study (average of the last 2 out of 3 measurements after 10 min rest)
  • Hypertensive patients whose treatment contains at least 2 antihypertensive molecules and whose treatment has been stabilised for at least :
  • 3 weeks in the case of the introduction or discontinuation of an anti-HBP drug
  • 2 weeks in the case of a change in the dosage of one of the anti-HBP drugs.
Show all 9Show fewer
  • Patients affiliated to a social security scheme
  • Patients who have signed the informed consent form (failing which, the legal representative)
  • Patients with dementia or with a severe reduction in physical function (impaired vision, asthenia, advanced osteoarthritis, severe tremors, etc.) and/or cognitive function may be included in this study with the agreement of their carers or family/relatives.

Who cannot join

  • Patients in whom no antihypertensive molecule can be reduced for specific reasons (heart failure with ejection fraction <40%, fluid retention due to heart failure, coronary artery disease and diabetic nephropathy).
  • Patients with an estimated life expectancy of <3 months
  • Patients who have already been included in this study or in another study at the same time

Trial locations and contacts

124 sites in 1 country.

124 sites in 1 country

France124 sites

  • CHU Angoulême (Expert center)

    Angoulême, 16000

  • Font Douce (Nursing Home)

    Angoulême, 16000

  • Keriolet (Nursing Home)

    Auray, 56400

  • Kerleano (Nursing Home)

    Auray, 56400

  • Le Parc de la Plesse (Nursing Home)

    Avrillé, 49240

  • Sentiers d'Automne (Nursing Home)

    Bains-les-Bains, 88240

  • Parisot (Nursing Home)

    Bainville-sur-Madon, 54550

  • EHPAD du CH (Nursing Home)

    Bar-sur-Seine, 10110

  • EHPAD Fontarce (Nursing Home)

    Bar-sur-Seine, 10110

  • USLD du CH (Nursing Home)

    Bar-sur-Seine, 10110

  • Saint Charles (Nursing Home)

    Bayon, 54290

  • Argia (Nursing Home)

    Bayonne, 64100

  • EHPAD du Prisse (Nursing home)

    Bayonne, 64100

  • Goxoki (Nursing Home)

    Bayonne, 64100

  • EHPAD CH de Valence (Nursing home)

    Beauvallon, 26800

  • EHPAD Simone de Beauvoir (Nursing Home)

    Béziers, 34500

  • Espace Perréal (Nursing Home)

    Béziers, 34500

  • USLD Espace Perréal (Nursing Home)

    Béziers, 34500

  • CHU Bordeaux (Expert center)

    Bordeaux, 33000

  • La Croix Du Gue (Nursing Home)

    Bouguenais, 44340

  • Poincaré (Nursing Home)

    Bouxières-aux-Dames, 54136

  • Les Rives d'Ode (Nursing Home)

    Carcassonne, 11000

  • Les jardin de Sophia (Nursing Home)

    Castelnau-le-Lez, 34057

  • EHPAD de Monges (Nursing Home)

    Castres, 81090

  • La Villégiale Saint Jacques (Nursing Home)

    Castres, 81090

  • Saint Martin (Nursing Home)

    Charmes, 88130

  • Saint Jean (Nursing Home)

    Charmois-l'Orgueilleux, 88270

  • EHPAD CH Cotentin Pasteur (Nursing Home)

    Cherbourg, 50100

  • Centre pour Personnes Agées (Nursing Home)

    Colmar, 68000

  • Diaconnat (Nursing home)

    Colmar, 68000

  • Chantereine-Orpea (Nursing Home)

    Coubron, 93470

  • Le Hameau de Saubagnacq (Nursing Home)

    Dax, 40088

  • CHU Dijon (Expert center)

    Dijon, 21000

  • EHPAD CHU Dijon Bourgogne (Nursing Home)

    Dijon, 21000

  • Les Bégonias (Nursing Home)

    Dijon, 21000

  • Les marguerites (Nursing Home)

    Dijon, 21000

  • Port du Canal (Nursing Home)

    Dijon, 21000

  • EHPAD Simone Veil (Nursing Home)

    Eaubonne, 95600

  • Bas-Château (Nursing Home)

    Essey-lès-Nancy, 54270

  • Belfontaine (Nursing Home)

    Fontaine-lès-Dijon, 21121

  • Accueil Vologne (Nursing Home)

    Granges-sur-Vologne, 88640

  • Vallée Don (Nursing Home)

    Guémené-Penfao, 44290

  • EHPAD Orpéa (Nursing home)

    La Talaudière, 42350

  • Baudinet De Courcelles (Nursing home)

    Lay-Saint-Christophe, 54690

  • CHU Lille (Expert center)

    Lille, 59000

  • Les Bateliers (Nursing Home)

    Lille, 59000

  • Saint Antoine de Padoue (Nursing Home)

    Lille, 59000

  • EHPAD de Lormont (Nursing Home)

    Lormont, 33310

  • Sainte Thérèse (Nursing Home)

    Ludres, 54710

  • Saint Charles (Nursing Home)

    Lunéville, 54300

  • CHU Lyon (Expert center)

    Lyon, 69000

  • EHPAD Constant (Nursing Home)

    Lyon, 69000

  • La Renaissance-Orpea (Nursing Home)

    Marseille, 13000

  • Bon repos (Nursing Home)

    Maxéville, 54320

  • Saint Sauveur (Nursing Home)

    Maxéville, 54320

  • Félix Marechal (Nursing Home)

    Metz, 57000

  • USLD Nouvielle (Nursing Home)

    Mont-de-Marsan, 40192

  • Coteaux de Montmorency (Nursing Home)

    Montmorency, 78428

  • Jeanne Callarec (Nursing Home)

    Montmorency, 78428

  • Antonin Balmès (Nursing Home)

    Montpellier, 34000

  • CHU Montpellier (Expert center)

    Montpellier, 34000

  • CSPA Bellevue (Nursing Home)

    Montpellier, 34000

  • EHPAD du CH (Nursing Home)

    Muret, 31600

  • Les Cygnes (Nursing Home)

    Nancy, 54000

  • Notre Maison (Nursing home)

    Nancy, 54000

  • Saint Charles EHPAD (Nursing Home)

    Nancy, 54000

  • Saint Charles USLD (Nursing Home)

    Nancy, 54000

  • Saint Joseph (Nursing Home)

    Nancy, 54000

  • Saint Stanislas (Nursing Home)

    Nancy, 54000

  • Gériatrie - CHRU de Nancy (Expert center)

    Nancy, 54500

  • Beauséjour (Nursing Home)

    Nantes, 44000

  • CHU Nantes (Expert center)

    Nantes, 44000

  • La Chézalière LNA Santé (Nursing Home)

    Nantes, 44000

  • CHU Nice (Expert center)

    Nice, 06000

  • EHPAD Cimiez du CHU (Nursing Home)

    Nice, 06000

  • EHPAD GHAM (Nursing Home)

    Nogent-sur-Seine, 10400

  • Bethel (Nursing Home)

    Oberhausbergen, 67205

  • Les Jardins d'Olonne (Nursing Home)

    Olonne-sur-Mer, 85340

  • Résidence Mer et Estuaire (Nursing Home)

    Paimboeuf, 44560

  • APHP (Expert center)

    Paris, 75000

  • EHPAD Broca (Nursing Home)

    Paris, 75013

  • La Collégiale (Nursing Home)

    Paris, 75013

  • Saint Jacques Orpea (Nursing Home)

    Paris, 75013

  • Trocadéro-Orpéa (Nursing Home)

    Paris, 75016

  • CHU Périgueux (Expert center)

    Périgueux, 24000

  • EHPAD Parrot (Nursing Home)

    Périgueux, 24000

  • USLD Pessac (Nursing Home)

    Pessac, 33318

  • Avant-Garde (Nursing Home)

    Pompey, 54340

  • La Salle (Nursing Home)

    Pompey, 54340

  • Nazareth (Nursing Home)

    Pont-Sainte-Marie, 10150

  • Saint Jean (Nursing Home)

    Portieux, 88330

  • Jacques Mellez (Nursing Home)

    Raon-l'Étape, 88110

  • CHU Reims (Expert center)

    Reims, 51100

  • AHPAD AB2 Wilson (Nursing Home)

    Reims, 51454

  • Résidence Roux CHU Reims (Nursing Home)

    Reims, 51454

  • Julien Monnard (Nursing Home)

    Romilly-sur-Seine, 10100

  • Le Clos des platanes (Nursing Home)

    Romilly-sur-Seine, 10100

  • EHPAD Mer Et Pins (Nursing Home)

    Saint-Brevin-les-Pins, 44250

  • Mer et Pins Fleur d'Ajonc (Nursing Home)

    Saint-Brevin-les-Pins, 44250

  • Mer et Pins les Sylphes (Nursing Home)

    Saint-Brevin-les-Pins, 44250

  • Saint Deodat (Nursing Home)

    Saint-Dié, 88100

  • Fauriel (Nursing Home)

    Saint-Etienne, 42000

  • EHPAD de Saint Genest (Nursing Home)

    Saint-Genest, 88700

  • Udazkena (Nursing Home)

    Saint-Jean-de-Luz, 64500

  • Hotel Club (Nursing Home)

    Saint-Max, 54130

  • EHPAD De Senones (Nursing Home)

    Senones, 88210

  • EHPAD Sézanne (Nursing Home)

    Sézanne, 51120

  • CHU Strasbourg (Expert center)

    Strasbourg, 67000

  • EHPAD Bois Fleuri (Nursing Home)

    Strasbourg, 67000

  • EHPAD CHRU Robertsau (Nursing Home)

    Strasbourg, 67000

  • La Christinière ACPPA (Nursing Home)

    Taluyers, 69440

  • Sainte Sophie (Nursing Home)

    Thiaucourt-Regniéville, 54470

  • CHU Toulouse (Expert center)

    Toulouse, 31000

  • Jolimont Marengo Orpea (Nursing Home)

    Toulouse, 31000

  • Clinique les Minimes (Nursing Home)

    Toulouse, 31200

  • Klarene-Orpea (Nursing Home)

    Tournan-en-Brie, 77220

  • CHP Cotentin Simone Veil (Nursing Home)

    Valognes, 50700

  • EHPAD Maison du Lac (Nursing Home)

    Vannes, 56000

  • USLD Maison du Lac (Nursing Home)

    Vannes, 56000

  • Sainte Catherine (Nursing Home)

    Verdun, 55100

  • Saint Joseph (Nursing Home)

    Ville-sur-Illon, 88270

  • Montagne de Reims (Nursing home)

    Villers-Allerand, 51500

  • Villa Saint-Pierre (Nursing Home)

    Villers-lès-Nancy, 54600

  • Les Buissons (Nursing Home)

    Xertigny, 88220

Other trials in France

About this study

Official title: Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP). Multicenter, Randomized Controlled Study of Subjects Aged 80 and Over, Living in Nursing Homes and Other IMS.

The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'.

Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP<130 mmHg with >1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.

Read the detailed description

High blood pressure (BP), principally systolic hypertension, is a common condition in older people and is considered a major determinant not only of cardiovascular morbidity and mortality, but also of several other age-related diseases, including frailty, cognitive decline and loss of autonomy. The Hypertension in the Very Elderly Treatment (HYVET) study showed the beneficial effect of antihypertensive treatment in patients ≥ 80 years. More recently, the Systolic Blood Pressure Intervention Trial (SPRINT) study showed that even in subjects 75 years and older, CVD outcomes and total mortality were reduced with intensive treatment as compared to the standard therapeutic strategies. However, both HYVET and SPRINT were conducted in selected populations since they excluded the most frail subjects, those with clinically significant cognitive decline and dementia, those with several cardiovascular and other co-morbidities, as well as patients living in medical-social institutions.

  • Interestingly, observational studies in these frail people, have shown no or even an inverse relationship between BP and morbidity and mortality. The PARTAGE longitudinal study was performed in 1130 subjects ≥ 80 years living in medical-social institutions. These subjects were receiving at mean 7.1 drugs/day; 2/3 of them were under antihypertensive drugs (mean 2.2 drugs/day). The PARTAGE study showed an over-mortality in hypertensive subjects with low SBP (<130 mmHg) treated with 2 or more antihypertensive drugs. These individuals, who represented 20% of the total studied population, exhibited 80% increase in mortality compared to all other groups, even after adjustment for several comorbidities.
  • The recent European guidelines for hypertension indicate that in people ≥ 80 years with SBP≥160 mmHg there is evidence to recommend reducing SBP to between 150 and 140 mmHg. However, no recommendation exists on which strategy to follow if treatment decreases SBP to lower levels (ex: 120 mmHg) especially on the more frail and polymedicated patients of that age. Thus, in this case, physicians can either continue the same treatment of reduce the number of drugs.
  • These contrasting results in old hypertensives reflects the enormous functional heterogeneity among individual of this age-group and clearly show that functional status rather than chronological age should guide therapeutic strategies. Thus, the guidelines for robust older individuals cannot be extrapolated to very old, frail individuals, who have been completely excluded from the above-mentioned clinical trials.

The only way is to conduct a controlled clinical trial.

Conditions
Hypertension
Being tested
STEP DOWN strategy, Control
Keywords
Blood pressure, Aged, Frailty, Polypharmacy
Medical subject headings
Hypertension, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STEP DOWN strategyOther

    reduction of the number of antihypertensive medication according to:

    • the systolic blood pressure levels,
    • co-morbidities

  • ControlOther

    usual treatment

Study groups in NCT03453268
Study groupRoleWhat they receive
1: Interventional (drug reduction)OtherSTEP DOWN strategy. Proposition of reduction of the number of antihypertensive medication according to: * the systolic blood pressure levels, * co-morbidities
Receives: Other: STEP DOWN strategy
2: ControlOtherUsual treatment
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    All-cause mortality in each of the two groups during follow-up (maximum 48 months depending on when the patient was included).

    Measured: up to 48 months

Secondary outcomes (9)

  1. Cause of death

    Occurrence of major CV events (myocardial infarction, hospitalisation for heart failure, stroke, other serious CV complication requiring specific management or hospitalisation)

    Measured: up to 48 months

  2. Blood pressure analysis

    SBP, diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR) in the sitting position (or supine if sitting is not possible) and standing position (if possible), during the 24 to 48 month follow-up period.s

    Measured: up to 48 months

  3. Evaluation of frailty

    Frailty tests: weight, muscle strength (handgrip), Short Physical Performance Battery (SPPB) and assessment of independence using the ADL (Activities of Daily Living) scale every 6 months during the follow-up period at medical visits.

    Measured: up to 48 months

  4. Evaluation of cognitive function

    Assessment of cognitive functions by MMSE (Mini Mental State Evaluation) every six months during the follow-up period at medical visits.

    Measured: up to 48 months

  5. Assesment of fall and fractures

    Number of falls and fractures

    Measured: up to 48 months

  6. Medication assessment

    Total number of medications: number of antihypertensive medications during the 24 to 48 month follow-up period.

    Measured: up to 48 months

  7. Evaluation of Quality of life

    Quality of life scales (EQ 5D) once a year during the follow-up period at medical visits.

    Measured: up to 48 months

  8. Onset of cardiac decompensation

    Occurrence of cardiac decompensation, whether fatal or not, and monitoring of changes in blood pressure.

    Measured: up to 48 months

  9. Patient at high risk of decompensation

    Number of patients at high risk of cardiac decompensation.

    Measured: up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start2 Oct 2018
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Therapeutic strategies: reduction of the antihypertensive treatment (intervention arm) vs. usual treatment (control arm)
Masking
None (open label)
Enrolment
1,048 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453268
Sponsor's protocol ID
P160602J
Other IDs
2017-A01646-47
Acronym
RETREAT-FRAIL
Status last verified
Jul 2025
First submitted
31 Jan 2018
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Benetos A, Gautier S, Freminet A, Metz A, Labat C, Georgiopoulos I, Bertin-Hugault F, Beuscart JB, Hanon O, Karcher P, Manckoundia P, Novella JL, Diallo A, Vicaut E, Rossignol P; RETREAT-FRAIL Study Group. Reduction of Antihypertensive Treatment in Nursing Home Residents. N Engl J Med. 2025 Nov 20;393(20):1990-2000. doi: 10.1056/NEJMoa2508157. Epub 2025 Aug 29.

    PubMed 40879421

Questions about this trial

What is this clinical trial studying?

A study testing STEP DOWN strategy in people with Hypertension, run by Assistance Publique - Hôpitaux de Paris at 124 sites in France.

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 3 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in France. 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?

All-cause mortality (time frame: up to 48 months). 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 NCT03453268, 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 20 Jul 2025.

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