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Cardio Vascular DiseaseHOPE-CRMNCT07819383

Holistic CRM Care vs Standard of Care in a Primary Care Setting

An observational study of Cardio Vascular Disease and Diabetes (DM), run by Danderyd Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Cardiovascular disease, high blood pressure, chronic kidney disease, and type 2 diabetes, collectively referred to as Cardio-Renal-Metabolic (CRM) conditions, are among the most common chronic diseases in society. Read more about this study

Who is it for?
Any age
What is being tested?
CRM care
How many people
6,000 participants
Where
No sites listed yet
Study dates
16 Sep 2026to 16 Sep 2031
How long will I take part?
4 Years
Phase
Observational

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: all patients with diagnoses within cardiovascular, kidney disease and type 2 diabetes, registered at units included in the study, with at least one visit during the study period

Who may be able to join

  • all patients with diagnoses within cardiovascular, kidney disease and type 2 diabetes, registered at units included in the study, with at least one visit during the study period

Who cannot join

  • no exclusion criteria

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kristina Lundwall, MD, PhD contact

+46731589999 ext. +46

kristina.lundwall@ki.se

Ladan Mansouri, MD, PhD contact

ladan.mansouri@ki.se

About this study

Official title: Holistic CRM Care vs Standard of Care in a Primary Care Setting. HOPE-CRM HOlistic Primary carE - Chronic Risk Management in CardioRenal Metabolic Disease

Cardiovascular disease, high blood pressure, chronic kidney disease, and type 2 diabetes, collectively referred to as Cardio-Renal-Metabolic (CRM) conditions, are among the most common chronic diseases in society. In Sweden, approximately 2.5 million people live with high blood pressure, one million have impaired kidney function, and more than half a million live with diabetes or heart disease. Many individuals are affected by more than one of these conditions at the same time, meaning that up to 30% of patients registered at an average primary care practice belong to this group.

These diseases are closely interconnected. Developing one condition substantially increases the risk of developing another, and the risk of cardiovascular events and other complications rises sharply as the number of diagnoses increases. As people live longer, it is becoming increasingly common for older adults to live with several chronic diseases simultaneously. This places a considerable burden on healthcare systems, both medically and economically.

Read more

At the same time, there is strong evidence that early, coordinated interventions can slow disease progression and reduce the risk of future complications. Despite clear national guidelines, there is still room for improvement in clinical practice. One important reason is that healthcare services and treatment guidelines remain largely organized around individual diagnoses rather than around the overall needs of each patient. As a result, different specialists often work in parallel, sometimes pursuing different treatment goals and strategies. This can lead to both under-treatment and over-treatment, contributing to unequal care and unnecessary burden for patients.

The CRM Centre at Danderyd Hospital provides an example of how integrated care can work in practice. There, assessment, treatment, and follow-up are delivered by a multidisciplinary team that takes the patient's entire disease profile into account. The model has produced promising results for patients with more complex medical needs. However, the vast majority of people with CRM-related conditions are managed within primary care.

This study evaluates a new primary care model that builds on the experience gained from the CRM Centre at Danderyd Hospital. The aim is to bring together all patients with CRM diagnoses within a common care structure and a unified treatment strategy. Participating primary care centres will receive education and access to practical support materials that integrate recommendations from guidelines covering all three disease areas. An important component is strengthened collaboration between primary and specialist care. Participating centres will have opportunities for clinical observerships, multidisciplinary digital case conferences with specialists at Danderyd Hospital, and targeted consultations regarding patients with CRM conditions through the Department of Internal Medicine at Ersta Hospital.

The project will be integrated into routine clinical practice without requiring additional patient visits. All patient management will be carried out by the responsible healthcare professionals, supported by the educational programme, clinical tools, and collaboration with specialist services. Using electronic health record data, national registers, and health economic analyses, the study will evaluate whether the model improves the use of evidence-based medications, increases achievement of treatment targets, and enhances cost-effectiveness. Long-term outcomes, including survival and rates of hospital admission, will also be assessed.

By bringing together care from multiple perspectives, this project addresses a clear and growing clinical need: providing patients with CRM conditions with more coordinated, effective, and equitable care. The findings are expected to be directly applicable across primary care and could inform future models for managing multimorbidity on a broader scale.

Being tested
CRM care
Medical subject headings
Diabetes Mellitus, Renal Insufficiency, Chronic

What participants receive

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

  • CRM careOther

    The study investigates a model of care

Study groups in NCT07819383
Study groupRoleWhat they receive
CRM careNot described
Receives: Other: CRM care

What is being measured

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

  1. CRM quality index

    To quantify the effect of patient-centered CRM care on guidelines-based health care quality with a special focus on cardiorenal protective treatment in clinical praxis.

    Measured: 1,5 years

Timeline

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

  1. First posted14 Sep 2026
  2. Study start16 Sep 2026 (estimated)
  3. Primary completion16 Sep 2028 (estimated)
  4. Study completion16 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819383
Sponsor's protocol ID
HOPE-CRM
Acronym
HOPE-CRM
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Sensitive data

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